Lidocaine Patch for Relief of Pain During Epidural Placement in Laboring Patients

This study has been withdrawn prior to enrollment.
(Study was stopped due to non-availability of the lidocaine placebo patches.)
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01307839
First received: March 1, 2011
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. To reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.


Condition Intervention
Pregnant
Labor
Drug: 5% lidocaine patch
Drug: placebo patch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of the Lidocaine Patch for Relief of Pain During Epidural Needle Insertion in Laboring Patients

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • To determine if the 5% lidocaine patch can decrease the pain from epidural placement. [ Time Frame: a minimum of 30 minutes from patch placement and a maximum of 12 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5% lidocaine patch
If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
Drug: 5% lidocaine patch
Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours.
Placebo Comparator: placebo patch
If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
Drug: placebo patch
Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Laboring patients between the ages of 18 and 45 with a BMI of less than 45

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307839

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Richard L Applegate, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Richard Applegate, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01307839     History of Changes
Other Study ID Numbers: 5110014
Study First Received: March 1, 2011
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
labor
epidural

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 22, 2014